Last Updated : February 7, 2023
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Melanoma Adjuvant Treatment
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0286-000
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Skin & Melanoma
Indications:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | March 28, 2022 |
| Call for patient/clinician input closed | May 20, 2022 |
| Clarification: - Patient input submission received from Melanoma Canada and Save Your Skin Foundation> | |
| Submission received | April 26, 2022 |
| Submission accepted | |
| Review initiated | May 11, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | July 26, 2022 |
| Deadline for sponsors comments | August 05, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 01, 2022 |
| Expert committee meeting (initial) | September 14, 2022 |
| Draft recommendation issued to sponsor | September 28, 2022 |
| Draft recommendation posted for stakeholder feedback | October 06, 2022 |
| End of feedback period | October 21, 2022 |
| Final recommendation issued to sponsor and drug plans | November 04, 2022 |
| Final recommendation posted | November 22, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 18, 2022 |
| CADTH review report(s) posted | February 06, 2023 |
Files
Last Updated : February 7, 2023